Avid Medical Recalls DAVINCI PACK Kits with Possible Foreign Material
Avid Medical recalls specific DAVINCI PACK convenience kits that may contain loose polypropylene foreign material, posing a potential risk during medical use.
Use caution until it’s fixed
Certain kits packed by the firm contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification.
Contact the company
What happened, in plain English
Avid Medical is recalling certain DAVINCI PACK convenience kits that may contain loose polypropylene foreign material. This could cause injury during medical procedures if the material becomes embedded in tissue. Read more at govinfonow.com/recall/73638-avid-medical-recalls-davinci-pack-kits-with-possible-foreign-material.
Source Summary by GovInfoNow · govinfonow.com/recall/73638-avid-medical-recalls-davinci-pack-kits-with-possible-foreign-material · Updated September 22, 2026 · FDA enforcement record: FDA #Z-0780-2018
Cite this page
“Avid Medical Recalls DAVINCI PACK Kits with Possible Foreign Material.” GovInfoNow, updated September 22, 2026. https://govinfonow.com/recall/73638-avid-medical-recalls-davinci-pack-kits-with-possible-foreign-material. Based on FDA recall #Z-0780-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0780-2018%22&limit=1).
Why it’s dangerous
The kits may contain loose polypropylene foreign material that could become embedded in tissue during medical procedures. This material might not be visible to the user and could cause injury if it becomes lodged in the body.
Who’s affected
Healthcare professionals using the recalled kits for medical procedures are most at risk. Patients receiving treatments with these kits may also be affected.
How to tell if you have this one
Check for the item code ADVU037-09 on the kit. The kits were sold with specific lot numbers: 1205900 (expiration 1/1/2019) and 1214034 (expiration 2/1/2019).
- Brand
Avid Medical- Category
Medical device
All 23 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0780-2018 | AVID TruCustom DAVINCI PACK convenience kits, Item Code: ADVU037-09; Lot, Expiration Date: 1205900, 1/1/2019; 1214034, 2/1/2019 | 50 |
| Z-0781-2018 | AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12; Lot, Expiration Date: 1205011 8/1/2019 1213805 10/1/2019 | 200 |
| Z-0782-2018 | AVID TruCustom OBSTETRICAL PACK convenience kits, Item Code: HLDH008-04; Lot, Expiration Date: 1203562, 12/1/2017; 1206458, 1/1/2018 | 48 |
| Z-0783-2018 | AVID TruCustom PACEMAKER TRAY convenience kits, Item Code: LAKC020-08 and LAKC020-09; Lot, Expiration Date: 1198747, 11/1/2018; 1199952, 10/1/2018; 1219974, 1/1/2019 | 70 |
| Z-0784-2018 | AVID TruCustom HEART CATH TRAY convenience kits, Item Code: LAKC022-06; Lot, Expiration Date: 1193636 ,1/1/2019; 1198134, 10/1/2019 | 354 |
| Z-0785-2018 | AVID TruCustom ORTHO TRAY convenience kits, Item Code: LGHM004-07 and LGHM004-08; Lot, Expiration Date: 1194408, 10/1/2018; 1204116, 10/1/2018; 1216669, 12/1/2018; 1216670, 11/1/2018 | 597 |
| Z-0786-2018 | AVID TruCustom CATH PACK convenience kits, Item Code: LGHM036-14; Lot, Expiration Date: 1190449, 2/1/2019; 1210124, 6/1/2019; 1217082, 8/1/2019; 1219275, 3/1/2019; 1221265, 3/31/2019; 1222551, 7/1/2019 | 444 |
| Z-0787-2018 | AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits, Item Code: LGHM033-04; Lot, Expiration Date: 1150308 ,1/1/2020 | 15 |
| Z-0788-2018 | AVID TruCustom EXTREMITY PACK convenience kits, Item Code: MADN012-01 and MADN012-02; Lot, Expiration Date: 1212610, 12/1/2017; 1218388, 8/1/2019 | 48 |
| Z-0789-2018 | AVID TruCustom GENERAL PACK convenience kits, Item Code: LGHM041-06 and LGHM041-08; Lot, Expiration Date: 1213947, 7/1/2019; 1216720, 10/1/2018; 1221271, 8/1/2017 | 630 |
| Z-0790-2018 | AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07; Lot, Expiration Date: 1191787, 7/1/2018; 1216674, 9/1/2019 | 160 |
| Z-0791-2018 | AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits, Item Code: MADN011-02; Lot, Expiration Date: 1197468, 8/1/2019; 1197469, 8/1/2019 | 24 |
| Z-0792-2018 | AVID TruCustom LAMINECTOMY PACK convenience kits, Item Code: MADN013-02; Lot, Expiration Date: 1197473, 6/1/2018; 1213733, 6/1/2018 | 12 |
| Z-0793-2018 | AVID TruCustom LOWER EXTREMITY convenience kits, Item Code: LGHM038-03 and LGHM038-04; Lot, Expiration Date: 1207468, 9/1/2019; 1216677, 9/1/2019; 1221264, 9/20/2019; 1222553, 9/1/2019 | 120 |
| Z-0794-2018 | AVID TruCustom MINOR PROCEDURE 6A convenience kits, Item Code: MADN032-01; Lot, Expiration Date: 1210946, 8/1/2018; 1211091, 10/1/2018; 1213010, 8/1/2018 | 44 |
| Z-0795-2018 | AVID TruCustom NEURO PK convenience kits, Item Code: LGHM021-08; Lot, Expiration Date: 1212598, 12/31/2018 | 46 |
| Z-0796-2018 | AVID TruCustom PACEMAKER PACK convenience kits, Item Code: LGHM030-06; Lot, Expiration Date: 1198253, 9/1/2018; 1213945, 7/1/2018 | 90 |
| Z-0797-2018 | AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits, Item Code: VAMK016; Lot, Expiration Date: 1211878, 7/1/2018 | 8 |
| Z-0798-2018 | AVID TruCustom PLASTIC BASIN PACK convenience kits, Item Code: MADN008-03; Lot, Expiration Date: 1203380 ,8/1/2018; 1203381, 8/1/2018; 1203382, 12/1/2018; 1211709, 12/23/2018 | 440 |
| Z-0799-2018 | AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03; Lot, Expiration Date: 1203390, 9/1/2019; 1203391, 12/1/2017; 1218389, 10/1/2019; 1218390, 10/1/2019 | 52 |
| Z-0800-2018 | AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02; Lot, Expiration Date: 1203383, 9/1/2018; 1217833, 12/31/2018; 1218421, 12/1/2018 | 24 |
| Z-0801-2018 | AVID TruCustom SPINE convenience kits, Item Code: LITT016-04; Lot, Expiration Date: 1211095, 3/1/2018; 1216086, 3/1/2018 | 30 |
| Z-0802-2018 | AVID TruCustom UPPER EXTREMITY convenience kits, Item Code: LGHM050-03 and LGHM050-04; Lot, Expiration Date: 1189012 , 7/1/2019; 1213716, 9/1/2019; 1216726, 10/1/2019 | 216 |
What to do — step by step
Check Kit Details
Look for the item code ADVU037-09 on the kit and verify the lot numbers (1205900 or 1214034).
Where it went and when
Where it was distributed
Distributed in 10 states.
FDA distribution: “Distributed in 10 states: IL, KY, LA, MA, MO, NY, OH, TX, VA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these kits immediately?
The recall does not require immediate stop use; healthcare professionals should check kit details and follow the provided steps.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0780-2018 (June 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0780-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 22, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.